Methods for determining cost-benefit ratios for pharmaceuticals in Germany.

The aim of this methodological paper is to summarize evidence on how to implement cost-benefit assessment according to the new German legislative framework (Competition Enhancement Act). Given the complexity of existing health policy frameworks within industrialised countries in adapting health economics in their respective regulatory scheme, no clear international scientific consensus on which health economic methods should be chosen for assessment can be determined. Nevertheless, a broad consensus on the internal properties of methods itself can be found. Based on these common international standards in methodology, this work provides a minimum catalogue of methods and criteria that meet legal and local German requirements with regard to specific factors of its health care system. Aside from categorising clearly defined standards (e.g., study forms, cost and benefit categories) the suggested catalogue specifies some intensively debated areas in Germany (e.g., the QALY, modelling, the perspective used in the assessment). After the proposition of certain methods the paper leads to a first recommendation of a detailed assessment-process itself specific for the German way in implementing cost-benefit ratios within regulatory decision making in Germany.